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510(k) Data Aggregation

    K Number
    K072869
    Device Name
    POINTCARE NOW SYSTEM
    Date Cleared
    2008-01-14

    (97 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    POINTCARE TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood. Whole blood samples can be analyzed with the PointCare NOW System for the following parameters: - White Blood Cell Count - Lymphocyte Count - Lymphocyte Percentage (of White Blood Cells) - CD4 T-Lymphocyte Count - CD4 Percentage (of total Lymphocytes) - Monocyte Count - Monocyte Percentage (of White Blood Cells) - Neutrophil Count - Neutrophil Percentage (of White Blood Cells) - Eosinophil Count - Eosinophil Percentage (of White Blood Cells) - Hemoglobin Concentration The PointCare NOW System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.
    Device Description
    The PointCare NOW System is a compact bench top immune hematology system that from analysis of a whole blood sample reports the hematology parameters identified within the Intended Use section below. The PointCare NOW System consists of an analysis instrument with an integrated touch screen interface and a commercially available tape roll printer. The CD4NOW Gold Pack is used within the PointCare NOW System and all assay steps are performed on whole blood with capped bar-coded reagents designed for use on the PointCare NOW System. All assay aspiration, dispensing and mixing steps are automated. The PointCare NOW System reports parameter results on the basis of software analysis of light scatter measurements with the use of non-fluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.
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    K Number
    K041882
    Device Name
    FLOWCARE SYSTEM
    Date Cleared
    2004-11-23

    (134 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    POINTCARE TECHNOLOGIES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FlowCare System is an automated immune hematology system intended for in vitro diagnostic use in the direct enumeration of White Blood Cell populations and certain T-lymphocyte subsets from human whole blood. Whole blood samples can be analyzed with the FlowCare™ System for the following parameters: - White Blood Cell Count . - Lymphocyte Percentage (of White Blood Cells) - . Lymphocyte Number - CD4 T-Lymphocyte Count . - CD4 Percentage (of total Lymphocytes) . The FlowCare System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.
    Device Description
    The FlowCare System is a compact benchtop immune hematology system that reports CD4 T-Lymphocyte count and percentage in conjunction with White Blood Cell (WBC) count, and total Lymphocyte count and percentage from analysis of a whole blood sample. The FlowCare System is comprised of an analysis instrument, a touch screen computer and a standard inkjet printer. The FlowCare CD4 Reagent Kit is used in conjunction with the FlowCare System. All assay steps are performed on whole blood with capped bar-coded reagent tubes designed for use on the FlowCare System. All assay aspiration, dispensing and mixing steps are automated. The FlowCare System reports parameter results on the basis of software analysis of light scatter measurements with the use of nonfluorescent reagents. Automated cell population cluster analysis is performed by the software and results provided with no operator interpretation.
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